Evaluation of the POWER2DM Diabetes Self-Management Support System Compared With Usual Care for Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 4
- 主要终点
- Change in glycemic control
研究概览
简要总结
Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Problems with adequate self-management usually underlie problems to maintain glycaemic control. Thus, patients need more support in order to reduce the burden and increase the effectiveness of their diabetes self-management. One way to do this is by using integrated technologies and personalized plans for diabetes care. For this purpose, the POWER2DM support system was developed to give patients insight into their condition and support diabetes patients and their health care professionals in setting and achieving self-management goals using predictive computer model simulations and behavioural action plans.
Objective: To provide proof of concept that POWER2DM is safe and effective in improving glycaemic control, improving behavioural/psychosocial and lifestyle markers, and to assess the cost-effectiveness of the approach and to highlight any potential issues that may impede implementation.
Study design: This is a pragmatic randomised controlled trial with 9 months follow-up in which patients will be randomised 1:1 to either Power2DM support (Power2DM group) or usual care (usual care group). There will be evaluation moments at baseline, after 11 weeks, 22 weeks and 37 weeks.
Study population: 230 patients with diabetes (N=115 type 1 diabetes (T1D), N=115 type 2 diabetes (T2D)) recruited from out-patient clinics in the Netherlands (Leiden University Medical Centre and affiliating teaching hospitals N=115) and Córdoba, Spain (Reina Sofia University Hospital N=115).
Intervention: The POWER2DM support group will receive access to the prototype 2 of the POWER2DM system. This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry.
Main study parameters/endpoints: Change in glucose regulation as measured by %HbA1c before and after the intervention compared between the intervention and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed T2DM or T1DM
- •Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher)
排除标准
- •Severe renal insufficiency (eGFR<30ml/min)
- •Serious/severe comorbidity that interferes with diabetes outcomes or diabetes self-management including but not limited to: psychiatric diseases, chronic hepatopathy, active malignancy, chronic obstructive pulmonary disease (COPD), disease of the digestive tract, endocrine disorders, cerebrovascular disease with disability
- •For female participants: pregnancy or wanting to become pregnant in the coming 9 months
- •Concurrent participation in other clinical trials
- •Any other situation in which the investigator identifies a potential risk of not being able to perform the study.
研究组 & 干预措施
POWER2DM support group
Participants in this group will receive access to the POWER2DM system as an adjunct to usual care. The participants have three intervention visits in which they will use the Shared Decision Making Dashboard to set self-management goals and will use the Self-Management Support system for trying to reach those goals in the periods after the intervention visits.
干预措施: POWER2DM system (Device)
Usual care group
Participants in this group will follow their usual diabetes care with their own diabetes care team.
干预措施: Usual care (Other)
结局指标
主要结局
Change in glycemic control
时间窗: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Change in HbA1c before and after the intervention compared between the intervention and control group
次要结局
- Body mass index (BMI)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Time spent in range(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- ADVANCE Kidney disease Risk(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- UKPDS risk score(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Q score(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Major Outcomes T1D(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Amount of steps(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Absolute means of daily differences (MODD)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- ADVANCE Cardiovascular risk(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Amount hypoglycemia(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Incidence of adverse events(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Mean amplitude of glycemic excursions (MAGE)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Self-reported exercise time(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Weight(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Cost-effectiveness(Over 37 weeks)
- Standard deviation of MBG (SDBG)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Frequency of self-monitoring of blood glucose (SMBG) measurements(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Patient utilities by EQ-5D(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Hypo unawareness(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Mean blood glucose (MBG)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Largest amplitude of glycemic excursions (LAGE)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Self-reported adherence to medication plan(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Diabetes Self-Management Questionnaire Revised (DSMQ-R)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Problem Areas in Diabetes (PAID)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Technology Acceptance Questionnaire (TAQ)(5 weeks and 37 weeks)
- Patient Assessment of Chronic Illness Care (PACIC)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
- Stress by perceived Stress Scale (PSS)(0 weeks, 11 weeks, 22 weeks and 37 weeks)
研究者
JKSont
Principal investigator, associate professor
Leiden University Medical Center